Events

Safety Alert for BVM (Bag-Valve-Mask) Manual Resuscitation Systems

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Intersurgical Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2018-01-09
  • Event Date Posted
    2018-01-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180109a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: intersurgical ltd bvm (bag-valve-mask) manual resuscitation systems the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a field safety notice concerning bvm (bag-valve-mask) manual resuscitation systems, manufactured by intersurgical ltd. the affected devices are identified as the following:- reference numbers (lot numbers): 7150000 (363791, 370252, 370751, 371638, 372887, 372894, 375508) 7151000 (364909, 370253, 371091, 371639, 372886, 372890, 375711) 7152000 (363792, 364270, 364923, 365216, 370266, 370752, 371640, 371656, 372888, 372889, 372893, 373638, 373639, 375411) 7152005 (31753284, 31756956, 31757575) 7152006 (31660106, 31753127, 31756716, 31757576, 31758289) 7152007 (371092) 7152012 (31753733, 31756957) 7153000 (363793, 370738, 371907, 372892, 375509) 7153008 (31753734) 7154000 (370753, 372367) a manufacturing fault has been identified with the intersurgical bvm manual resuscitation system, which could result in the directional valves positioned on the ‘back plate’ of the self-inflating bag being orientated incorrectly. the incorrect orientation of the directional valves could result in the bvm manual system becoming over pressurised, which could result in patient barotrauma. according to the manufacturer, bvm manual resuscitation systems with alternative directional valves configuration positioned on the ‘back plate’ are not affected by this fsn and are safe to use. affected users are instructed to quarantine and stop the use of all affected devices. if no suitable replacement is available, users should check the orientation of the valves on the back plate of the self-inflating bag and ensure they are orientated correctly. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-2-to-5-january-2018 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 09 january 2018.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Intersurgical Ltd BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Manufacturer
    Intersurgical Ltd

Manufacturer

Intersurgical Ltd